The chemical name for budesonide is 16,17-(butylidenebis(oxy))-11,21-dihydroxy-, (11-β,16-α)-pregna-1,4-diene-3,20-dione, and its chemical structure is shown, below:

Budesonide is the active ingredient in a gastrointestinal pharmaceutical formulation directed to the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, and the maintenance of clinical remission of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Some conventional formulations utilize a non-pareil seed and two coatings, wherein the first coating comprises budesonide embedded in an extended release polymer, and the second coating comprises a pH dependent coating for delayed release. Alternative conventional formulations include a pellet core comprising budesonide, and at least two coatings thereon. However, the conventional formulations have numerous limitations. For example, the pellet coating process is both difficult and lengthy, because the pellets tend to agglomerate. Moreover, extended release coatings on pellets, especially coatings involving ethylcellulose, require an additional curing step to prevent a decrease in dissolution rate over time.
Consequently, there is a need for improved budesonide formulations which are easier to manufacture, while maintaining a desirable dissolution profile.